Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

A Single-centre, Double Blind, Randomised Controlled Clinical Trial to Evaluate the Effect of Electrical Pharyngeal Stimulation as a Treatment for Stroke-related Dysphagia in Tracheostomized Stroke Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01956175

Enrollment

Registered

2013-10-08

Start date

2013-06-30

Completion date

2014-12-31

Last updated

2015-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Stroke

Keywords

electrical pharyngeal stimulation, stroke-related dysphagia, tracheostomy, decannulation

Brief summary

The purpose of this study is to evaluate whether electrical pharyngeal stimulation in addition to standard care can enhance short-term swallow recovery in tracheostomized dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham treatment plus standard care.

Detailed description

Readiness for decannulation is assessed after three days of either real or sham electrical pharyngeal stimulation. In case a patient cannot be decannulated at that time point, there is an open-label follow-up treatment phase, in which every patient in the sham treatment arm gets another three days of real electrical pharyngeal stimulation to not deprive any patient of a potentially beneficial treatment.

Interventions

DEVICEElectrical pharyngeal stimulation

Electrical pharyngeal stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.

DEVICESham stimulation

The intraluminal catheter (Phagenesis Ltd.) for electrical pharyngeal stimulation is placed. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After the optimal stimulation intensity has been determined, no electrical stimulation is delivered.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* severe dysphagia due to acute stroke * completely weaned from mechanical ventilation * impossibility of decannulation because of severe dysphagia with ongoing aspiration

Exclusion criteria

* preexisting dysphagia * comorbidities that can possibly cause dysphagia * psychiatric comorbidities * pacemaker or other implanted electronic devices

Design outcomes

Primary

Measure	Time frame	Description
Readiness for decannulation	3 days	Difference in readiness for decannulation as assessed by a standardized fiberoptic endoscopic evaluation protocol after three days of treatment between real and sham treatment groups

Secondary

Measure	Time frame
Functional Oral Intake Scale (FOIS) at discharge	until discharge
modified Rankin Scale (mRS) at discharge	until discharge
length of stay on ICU / in the hospital and time from stimulation to discharge	until discharge

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026